|Dear Seed Investor,
NetworkNewsWire Editorial Coverage: The $58.6 billion global market for pain management drugs is on track to hit upwards of $77.1 billion by 2023 on a four percent CAGR. North America was the largest segment of this massive market last year, and opioids were the biggest driver of growth due to their efficacy in managing severe chronic pain. However, this efficacy is dramatically offset by the enormous economic cost of what is now officially a nationwide crisis. Opioid abuse, addiction and overdose deaths cost an estimated 2.8 percent of GDP in 2015 alone (over $504 billion) according to the Council of Economic Advisers. This escalating public health crisis has thrown a bright spotlight on new pain management alternatives void of addictive components and reduced adverse side effects.
The need for alternatives like cannabinoid-based therapies is generating significant market interest for prospective solution developers such as InMed Pharmaceuticals, Inc. (CSE: IN) (OTCQB: IMLFF) (IMLFF profile), a preclinical-stage biopharmaceutical company focused on developing its pipeline of novel therapies based on the integration of the pharmacology of cannabinoids and innovative drug delivery systems. InMed’s approach to the therapeutic potential of cannabinoids is what differentiates it from others in the biotech space: GW Pharmaceuticals (NASDAQ: GWPH), Zynerba Pharmaceuticals (NASDAQ: ZYNE), Cara Therapeutics, Inc. (NASDAQ: CARA) and Axim Biotechnologies (OTC: AXIM).
While most cannabis-focused biotechs funnel their resources and time into the development of medicines using the two most common cannabinoids - tetrahydrocannabinol (THC) and cannabidiol (CBD) - InMed Pharmaceuticals, Inc.’s (CSE: IN) (OTCQB: IMLFF) proprietary biosynthesis process has demonstrated capabilities that allows the company to consistently manufacture all of the 90+ naturally-occurring cannabinoids in-house, eliminating the expenses of growing or buying cannabis plant matter to develop its pipeline of therapies.
The company’s ability to create bio-identical, pharmaceutical-grade cannabinoids is a crucial differentiator that enables InMed to also address two primary challenges to the research and development of cannabinoids. Typically, the research of cannabinoids for the treatment of disease is 1. Obstructed by the fact that these compounds occur in very low concentrations of the cannabis plant; and 2. Limited due to the exorbitant costs of isolating sufficient quantities of cannabinoids needed to conduct research.
InMed’s proprietary biosynthesis technology, however, is a game changer, placing the ability to extract high yields of minor cannabinoids within the realm of commercial viability and unprecedented medical research.
This is particularly key as the company advances its INM-405 candidate for the treatment of pain. Recent pre-clinical data from the company’s pain treatment program (http://nnw.fm/4ICzO) suggests that topical application of certain non-THC cannabinoid compounds is effective in treating peripheral pain in craniofacial muscle pain disorders.
This achievement builds on the company’s proof-of-concept study results published earlier this year in the European Journal of Pain, suggesting that THC could reduce masticatory muscle pain through the activation of peripheral cannabinoid receptors CB1 and CB2, which are primary targets in the human body for cannabinoid drugs.
As the need remains for non-addictive pain management alternatives with limited side effects, InMed continues to research the potential of non-THC cannabinoids to treat pain using a topical formulation. The company recently filed a provisional patent application in the U.S. for INM-405 and other unique cannabinoid-based topical therapies for the treatment of pain, recognizing that the significant unmet need for a topical analgesic without the typical systemic exposure and side effects represents a huge target.
InMed’s chief scientific officer and co-inventor on the patent, Dr. Sazzad Hossain, in a press release announcing the filing was keen to point out how InMed's focus on non-psychoactive cannabinoids further reduces the entire industry’s prevailing concerns about addiction.
"There remains a significant need in the field of analgesia for a product that can treat pain via a topical route of administration, which would reduce systemic exposure and any associated side effects," he stated in the press release (http://nnw.fm/xc4uV). "InMed's focus on non-psychoactive cannabinoids further reduces concerns regarding addiction, a key concern in pain management."
According to the Centers for Disease Control (“CDC”), more than 60,000 people in the United States were killed by drug overdoses in 2016, an increase of 22 percent compared to the year prior. Drug overdoses are expected to remain the leading cause of death in Americans under the age of 50, and the CDC report notes that synthetic opioids are leading to an uptick of drug-related deaths as the use of fentanyl alone more than doubled from 2015 to 2016 (http://nnw.fm/i0LWV).
In light of these statistics, the race is heating up for a way to curb the dramatic increase in the number of prescriptions for opioids. A topical cannabinoid product for pain management, particularly a non-THC based one, could be just the ticket.
InMed’s INM-405 patent cites a range of topically applied cannabinoids (alone or in combination) for the treatment of a variety of pain types ranging from muscle and nerve to arthritis-induced joint pain, providing for the company an opportunity to tap into the osteoarthritis market, expected to reach $3.5 billion by 2026, and the market for orofacial pain, pegged at $6 billion a year.
This approach not only represents a vastly preferable solution compared to orally-administered pain relievers, it dovetails perfectly with InMed’s biosynthesis program to produce commercial quantities of cannabinoids for other candidates in is pipeline, which includes INM-750 for the treatment of Epidermolysis Bullosa (genetic condition characterized by fragile, blistering skin), and INM-085 for the treatment of the optic nerve-damaging, degenerative disease glaucoma.
As InMed focuses on scaling-up and commercializing this biosynthesis platform, the company has tapped leading cannabinoid researchers to assist with its progress. In September the company retained the consulting services of Ben Paterson, P.E., who has nearly four decades of experience in developing pharmaceutical manufacturing and purification processes, including all facets of biosynthesis manufacturing and facility design (http://nnw.fm/Ug7Ok). Paterson was previously a senior engineering advisor with Eli Lilly and Company, where he spent 37 years, including 24 years in its biosynthesis division. InMed next named to its Scientific Advisory Board Dr. Mauro Maccarrone, professor and chair of biochemistry and molecular biology at Campus Bio-Medico, University of Rome (http://nnw.fm/3DYAn).
InMed’s ongoing development of its proprietary biosynthesis platform recently saw what the company believes to be two significant industry firsts (http://nnw.fm/S9H3z): a new and substantially more robust metabolic pathway capable of manufacturing much sought after terpenoid ) family of cannabinoid precursors (diverse organic compounds typically in the form of aromatic oils, as well as the first production of fully-assembled cannabinoids that are bio-identical to the 90+ known plant-based cannabinoids.
This unique technological advantage not only gives InMed a serious leg up when it comes to cost-effectively producing the raw materials the company needs to advance its own pipeline. InMed’s captivating biosynthesis technology could also have a major impact on other biotech companies developing cannabinoid-based therapeutics as well. This technology has the potential to become an industry standard when it comes to cost-effectively obtaining large quantities of the many different cannabinoids required by tomorrow’s breakthrough therapies.
GW Pharmaceuticals plc (NASDAQ: GWPH), which is looking at an NDA decision from the FDA on orphan drug designated Epidiolex (purified, plant-derived cannabidiol) for Dravet syndrome and Lennox-Gastaut syndrome (epilepsies) by as early as the middle of 2018, is a prime example. The company is also prepping for European regulatory approval coming off a landmark publication in The New England Journal of Medicine, as well as key presentations at the American Academy of Neurology and American Epilepsy Society annual meetings. GW Pharmaceuticals is also advancing a number of additional clinical programs and could make good use of a cost-effective, robust and more articulable process for obtaining the raw materials that go into its indications.
Zynerba Pharmaceuticals (NASDAQ: ZYNE), developer of indications like ZYN002, the first and only pharmaceutically-produced CBD, is another good example. A permeation-enhanced transdermal gel, ZYN002 is targeting the developmental genetic condition known as Fragile X syndrome (orphan drug designation obtained), as well as focal seizures and osteoarthritis. The company is also advancing a pro-drug of THC called ZYN001 for fibromyalgia and peripheral neuropathic pain. The company cites clinical data suggesting that THC and CBD have a high therapeutic index with low toxicity in support of its development pipeline’s potential. And it is intriguing to imagine a future where biosynthesis technology bridges the gap between the benefits of natural plant extracts, and laboratory manufactured, pharmaceutically-produced cannabinoid variants.
Cara Therapeutics (NASDAQ: CARA) is investigating the endogenous system of ligands in humans discovered through research into the effects of cannabis, as well as the primary CB1 and CB2 cannabinoid receptors activated thereby. Found respectively in nervous system tissues and peripheral tissues like those that make up the immune system, these cannabinoid receptors and the associated ligands have been shown to be substantially involved in things like pain and inflammatory response. Cara Therapeutics’ approach is to focus on specific molecules that are able to selectively modulate cannabinoid receptors in peripheral tissues, without actually triggering those in the central nervous system, with the goal of addressing neuropathic pain. The company’s lead candidate in this area, CR701, is still in the pre-clinical phases. But, the company anticipates that such cannabinoid receptor agonists have tremendous potential when it comes to relieving neuropathic pain, ranging from allodynia (perception of pain from normal stimuli) to hyperalgesia (increased perception of pain as a result of taking opioids to treat it).
Axim Biotechnologies (OTCQB: AXIM) has a broad array of cannabinoid indications under development that leverage the company’s innovative pharmaceutical delivery systems and APIs (active pharmaceutical ingredients). With offerings under development ranging from the MedChew line of pharmaceutical, functional chewing gums containing cannabinoids. To the proprietary, patent-pending topical ointment formulation AX-1602, which includes the company’s “stem cell cannabinoid” cannabigerol. Axim is precisely the kind of multi-front developer which could benefit mightily from InMed’s biosynthesis technology.
The mounting need to find effective, non-addictive alternatives to existing medications like opioids for treating chronic and severe pain in particular will continue to draw attention to trailblazers such as InMed. The potential of cannabinoid-based therapies, which lack the crippling and even deadly side effects of opioids, is only starting to be properly understood when it comes to addressing these objectives. The ability to produce large quantities of otherwise not commercially viable cannabinoids, for select combination therapies that can be administered topically, is quite possibly the most disruptive development yet witnessed in the still-young cannabinoid therapy space.
Thus, a company like InMed, with an attractive pipeline under development and proprietary biosynthesis technology it can exploit or even license out, is one for investors to really keep an eye on.
For more information on InMed Pharmaceuticals, please visit: InMed Pharmaceuticals, Inc. (CSE: IN) (OTCQB: IMLFF)
The Seed Investor